This invention relates to a gastric banding device that encircles a portion of the stomach to form a stoma opening of reduced diameter.
Morbid obesity is associated with medical risks in terms of the development of additional diseases such as diabetes, hypertension, cardiac insufficiency and other socio-psychological problems, overall reducing life expectancy. Dietary management, psychiatric or dietary regiments are the first choice for treating morbid obesity, but as they depend on the goodwill of the patient, especially in the long run, these approaches often fail.
Various surgical approaches have been developed and used for treating morbid obesity. These include gastric bypasses, small bowel bypasses and stapling of portions of the stomach. The stapling techniques include horizontal and vertical stapling for reducing the volume of the stomach, as well as narrowing the stoma opening thus controlling the food intake of the stomach. However the latter approach, stapling, may not bring the desired results due to the fact that the staples frequently open or tend to cause perforations. Furthermore the stomach opening formed by staples widens over time, thus the effect is reduced or even eliminated.
A different approach to the problem specified above is described in U.S. Pat. No. 4,416,267, which discloses a method for treating obesity by placing an inflatable balloon into the stomach. Such a device displaces volume inside the stomach, thereby reducing the effective free volume of the gastric portion causing the individual to feel no need for additional food intake. The balloon is inflated in the stomach to a predetermined volume and is left there for a certain period of time after which it is easily removed. However, this procedure although being physically easy to implement and basically being non-surgical, may lead to harmful results. The inflated balloon in the stomach is in constant contact with gastric mucous, and such contact for an extended period of time may give rise to gastric ulcers and intestinal blockage.
Recently, another approach has been developed based on placing a physical means (i.e. a gastric band) outside the stomach. A gastric band is placed around the upper part of the stomach, thereby creating an altered stomach opening of a reduced diameter, resulting in the restriction of food intake into the digestive portion of the stomach. Such a gastric-banding technique is simple as compared to the above-mentioned balloon-based technique. However, this band has no means for adjusting its diameter to obtain the optimal diameter of the stomach opening.
Adjustable gastric bands have been developed, and disclosed for example in U.S. Pat. No. 4,592,339, as well as in xe2x80x9cA Gastric Band with Adjustable Inner Diameter for Obesity Surgeryxe2x80x9d, P. Forsell et al., Obes Surg., 1993, No. 3, pp. 303-306. According to this technique, the diameter of a belt-like band, when in a closed position thereof, may be adjusted. For this purpose, the band includes an inflatable portion in its interior part. Controllable inflating and deflating of this portion alters the stomach opening. Although this gastric band can retain the predetermined diameter of the stomach opening, obtaining of the proper opening is somewhat problematic.
U.S. Pat. No. 4,696,288 discloses a calibrating apparatus for using with a gastric band for controlling the diameter of the stomach opening by regulating the band""s diameter. Such a gastric band is typically mounted with a laproscopic technique, disclosed for example in U.S. Pat. No. 5,226,429.
It is a main object of the present invention to provide a gastric band of a belt type, which can be attached to a patient""s stomach in a safe manner and without damaging the stomach circumference.
It is a further object of the present invention to provide such a band which can be easily mounted on the stomach utilizing a laproscopic technique.
It is a still further object of the present invention to provide such a band that is easily enables its facile detectable by any suitable imaging means, thereby facilitating access to the band when additional surgical/laproscopic intervention is desired.
There is thus provided according to one aspect of the present invention, a gastric band for attaching around a circumference of a patient""s stomach so as to define the diameter of the stomach opening, the band comprising:
(a) outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof;
(b) a through-going opening made in said member and located so as to define an end portion of the band having a predetermined length; and
(c) an opposite end portion of the band shaped so as to be insertable into said through-going opening for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.
The gastric band is of a belt type, and also comprises a suitable fastening means, which may utilize a required number of stitches or the provision of bolt-and-nut arrangements on the band. The fastening means may also be in the form of teeth-like edges of the opposite end portion and a correspondingly shaped through-going opening.
The outer and inner surface may be formed either of the same material, or of different materials, provided that the material of the outer surface is substantially not-extendable.
Preferably, at least the outer surface of the band is made of poly-tetra-fluoro-ethylene, known as Gortex. The material of the inner surface of the band engaging the stomach may be silicone. The band, when in the operation position thereof is such that its inner surface engaging the stomach has a substantially circular shape.
The predetermined length of the end portion is such as to enable the detection of the gastric band by a laproscopic inspection tool.
According to another aspect of the present invention, there is provided a system for laproscipically attaching a gastric band around a patient""s stomach so as to define a certain diameter of the stomach opening,
the system comprising a calibration device which is insertable into the stomach at a predetermined depth and comprises:
an upper portion having variable volume, and
a lower projection-like portion having a diameter substantially equal to said certain diameter of the stomach opening to be defined by the band, the location of said projection-like portion when in the inserted position of the calibration device defining the location of the band with respect to the stomach;
said band comprising:
outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof;
a through-going opening made in said member and located so as to define an end portion of the band having a predetermined length; and
an opposite end portion of the band shaped so as to be insertable into said through-going opening for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.